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FDA NDA · NDA050697

BIAXIN XL

Sponsor: ABBVIE INC

APPLICATION
NDA050697
TYPE
NDA
ORIGINAL APPROVAL
1993-12-23
LATEST ACTION
2004-07-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BIAXIN XLDiscontinued
CLARITHROMYCIN 250MG · TABLET · ORAL
BIAXIN XLDiscontinued
CLARITHROMYCIN 500MG · TABLET · ORAL

Approval history

2004-07-19Labeling · Supplement 3 · standard — Letter ↗AP
2002-05-24Efficacy · Supplement 2 · standardAP
1993-12-23Type 6 - New Indication (no longer used) · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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